FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA MONITOR
MDR report key: 383953
·
Received March 16, 2002
Report
- Report Number
- 1220459-2002-00022
- Event Type
- Malfunction
- Date Received
- March 16, 2002
- Date of Event
- February 11, 2002
- Report Date
- March 14, 2002
- Manufacturer
- MEDISENSE, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COMPLAINT INVESTIGATION WHEN A CONSUMER REPORTED RECEIVING A HIGH READING OF 81 MG/DL ON A MEDISENSE PRECISION XTRA MONITOR WHEN COMPARED TO A VALID LABORATORY COMPARISON OF 44 MG/DL. THESE VALUES, WHEN PLOTTED ON A CLARKE ERROR GRID, FELL INTO THE "D" ZONE SHOWING THEM TO BE CLINICALLY SIGNIFICANT. NO DEATH, SERIOUS INJURY OR EMERGENCY MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION XTRA MONITOR | BLOOD GLUCOSE METER | CFR | MEDISENSE, INC. | NA | 87968 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |